Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Change
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf life change was made without submitting data to demonstrate continued product efficacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific injuries or illnesses are reported, as the hazard involves potential loss of efficacy rather than direct physical harm.
Plain-English summary
Straumann Manufacturing, Inc. is recalling 2,816 units of Straumann Emdogain 0.3 ml Multipack USA (Article Number 075.113). The product is an Enamel Matrix Derivative used in medical procedures. The recall covers specific lots: MZ538 (Exp 9/4/2018), NJ580 (Exp 9/30/2018), NK215 (Exp 3/31/2019), and NP343 (Exp 3/31/2019).
The recall was initiated because a change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. This is an FDA Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed nationwide in the United States and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or the manufacturer for credit or replacement, as directed by Straumann Manufacturing.
The recalled product
- Product
- Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
- Manufacturer
- Straumann Manufacturing, Inc.
- Affected units
- 2,816
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot MZ538
- Syringe Blister Lot MG253B
- Exp 9/4/2018 Lot NJ580
- Exp 9/30/2018 Lot NK215
- Syringe Blister Lot NE101A
- Exp 3/31/2019 Lot NP343
- Exp 3/31/2019
Distribution
Part of a larger recall action
This product is one of 6 recalled by Straumann Manufacturing, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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